Duns Number:551540334
Device Description: Senti Desktop Flex Screening SetContent:1. Case AN1005032. Inlay Sentiero AN1003853. Senti Senti Desktop Flex Screening SetContent:1. Case AN1005032. Inlay Sentiero AN1003853. Senti Desktop Flex device AN1004334. Headphone DD-45 AN1003065. FW Labelprinter AN1004146. FW Pure Tone Audiometer Class 4 Advanced AN1006537. Power supply AN100524 + AN100525-USA or AN101360 + 101251-USA optionally8. USB data cable AN100418
Catalog Number
-
Brand Name
Senti Desktop Flex
Version/Model Number
100470-SC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
c9c57c57-9579-463d-9362-c6015f669544
Public Version Date
September 29, 2022
Public Version Number
2
DI Record Publish Date
June 27, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |